Browse Device Recalls
1,382 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 1,382 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.
Medical Device Recalls
Browse 1,382 FDA device recalls in NY.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Mar 14, 2016 | Xcela Hybrid PICC with PASV Valve Technology, MST-70 Kit, 6F-55cm, UPN H96595... | PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing spe... | Class II | Navilyst Medical, Inc., an AngioDyamics Company |
| Mar 14, 2016 | BioFlo Hybrid PICC with ENDEXO and PASV Valve Technology, MST-70 Kit, 6F-55cm... | PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing spe... | Class II | Navilyst Medical, Inc., an AngioDyamics Company |
| Mar 14, 2016 | Xcela Hybrid PICC with PASV Valve Technology, IR-145 Kit, 6F-55cm, UPN H96595... | PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing spe... | Class II | Navilyst Medical, Inc., an AngioDyamics Company |
| Mar 14, 2016 | Vaxcel PICC with PASV IR-145 Kit under the following labels: 1) 4F, UPN M0014... | PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing spe... | Class II | Navilyst Medical, Inc., an AngioDyamics Company |
| Mar 14, 2016 | Xcela Hybrid PICC with PASV Valve Technology, Catheter Kit, 6F-55cm, UPN H965... | PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing spe... | Class II | Navilyst Medical, Inc., an AngioDyamics Company |
| Mar 14, 2016 | BioFlo PICC with ENDEXO and PASV Valve Technology, IR-145 Kit, 6F-55cm, UPN H... | PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing spe... | Class II | Navilyst Medical, Inc., an AngioDyamics Company |
| Mar 14, 2016 | Xcela Hybrid PICC with PASV Valve Technology, Intermediate MST-45 Kit, 6F-55c... | PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing spe... | Class II | Navilyst Medical, Inc., an AngioDyamics Company |
| Mar 14, 2016 | Xcela PICC with PASV Valve Technology, MST-70 Kit, 6F-55cm, UPN H965251290 & ... | PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing spe... | Class II | Navilyst Medical, Inc., an AngioDyamics Company |
| Mar 14, 2016 | Xcela PICC with PASV Valve Technology, IR-145 Kit, 6F-55cm, UPN H965457430, R... | PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing spe... | Class II | Navilyst Medical, Inc., an AngioDyamics Company |
| Mar 14, 2016 | BioFlo Hybrid PICC with ENDEXO and PASV Valve Technology, IR-145 Kit, 6F-55cm... | PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing spe... | Class II | Navilyst Medical, Inc., an AngioDyamics Company |
| Mar 14, 2016 | Vaxcel PICC with PASV Intermediate Safety MST Kit under the following labels:... | PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing spe... | Class II | Navilyst Medical, Inc., an AngioDyamics Company |
| Mar 14, 2016 | Vaxcel PICC with PASV MST-60 Kit under the following labels: 1) 3F, UPN H9654... | PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing spe... | Class II | Navilyst Medical, Inc., an AngioDyamics Company |
| Mar 14, 2016 | BioFlo PICC with ENDEXO and PASV Valve Technology, Catheter Kit, 6F-55cm, UPN... | PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing spe... | Class II | Navilyst Medical, Inc., an AngioDyamics Company |
| Mar 14, 2016 | Xcela PICC with PASV Valve Technology Catheter Kit, 6F-55cm, UPN H965457410, ... | PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing spe... | Class II | Navilyst Medical, Inc., an AngioDyamics Company |
| Mar 14, 2016 | BioFlo PICC with ENDEXO and PASV Valve Technology, MST-45 Kit, 6F-55cm, UPN H... | PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing spe... | Class II | Navilyst Medical, Inc., an AngioDyamics Company |
| Mar 14, 2016 | Vaxcel PICC with PASV Introducer Kit under the following labels: 1) 4F, UPN M... | PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing spe... | Class II | Navilyst Medical, Inc., an AngioDyamics Company |
| Mar 14, 2016 | Vaxcel PICC with PASV Catheter Kit under the following labels: 1) 3F, UPN H96... | PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing spe... | Class II | Navilyst Medical, Inc., an AngioDyamics Company |
| Mar 10, 2016 | ADVIA 560 Hematology Systems, Siemens Material Number (SMN) 11170842, IVD ... | Software anomaly; Siemens identified that software version 1.4.2133 on the ADVIA 560 Hematology S... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Mar 10, 2016 | HIgH-Flo Subcutaneous Safety Needle Sets, 2-Needle Set/ 24 Gauge 9mm Needles,... | On 2/24/2016 during post sterilization inspection of part number F180 Precision Flow Rate Tubing,... | Class II | Repro-Med Systems, Inc. |
| Mar 10, 2016 | Freedom60 Precision Flow Rate Tubing Sets, REF/Part Numbers F900, F2400, F60,... | On 2/24/2016 during post sterilization inspection of part number F180 Precision Flow Rate Tubing,... | Class II | Repro-Med Systems, Inc. |
| Mar 7, 2016 | ADVIA Chemistry Triglyceride_2, concentrated; TRIG_c; Catalog # SMN # 1069757... | Siemens Healthcare Diagnostics has confirmed the ADVIA Chemistry Triglyceride concentrated reagen... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Mar 3, 2016 | dynarex Specimen Containers, Screw-On, Leak-Resistant Lid, Tamper-Evident Sea... | Exterior carton is mis-labeled as Sterile. Non-sterile, bulk specimen containers were packed in ... | Class II | Dynarex Corporation |
| Mar 3, 2016 | Bigger-Better-Bladder With 3/8" ID tubing, ITEM BBB38 | The seal between the balloon and the housing may leak. | Class II | Circulatory Technology Inc |
| Mar 2, 2016 | IMPAK Liquid Acrylic Resin sold under the following labels: 1) IMPAK PF PINK... | Possible presence of foreign material (rust). | Class II | CMP Industries, Llc |
| Feb 18, 2016 | 1) VITROS¿ Immunodiagnostic Products Total Beta-hCG II Reagent Pack (Unique ... | When testing was conducted using certain lots, VITROS¿ Systems generated results within the measu... | Class II | Ortho-Clinical Diagnostics |
| Feb 17, 2016 | EZ adjust aluminum crutch under the following labels: 1) EZ adjust aluminum c... | Tip crutch failure involving the bottom of the metal portion which comes in contact with ground | Class II | Medical Depot Inc. |
| Feb 17, 2016 | Aluminum crutch under the following labels: 1) Aluminum crutch, adult, 1 pair... | Tip crutch failure involving the bottom of the metal portion which comes in contact with ground | Class II | Medical Depot Inc. |
| Feb 17, 2016 | Universal Quick Adjust under the following labels: 1) Aluminum crutch, adult,... | Tip crutch failure involving the bottom of the metal portion which comes in contact with ground | Class II | Medical Depot Inc. |
| Feb 17, 2016 | Universal aluminum crutch, 1 pair per case Aid the user in walking while r... | Tip crutch failure involving the bottom of the metal portion which comes in contact with ground | Class II | Medical Depot Inc. |
| Feb 17, 2016 | Direct Supply aluminum crutch, adult, 1 pair per case Aid the user in walk... | Tip crutch failure involving the bottom of the metal portion which comes in contact with ground | Class II | Medical Depot Inc. |
| Feb 17, 2016 | Universal Quick Adjust under the following labels: 1) Aluminum crutch, adult,... | Tip crutch failure involving the bottom of the metal portion which comes in contact with ground | Class II | Medical Depot Inc. |
| Feb 16, 2016 | VITROS 5600 Integrated System, Unique Device Identifier No. 10758750002740 & ... | The two sets of wires (4 total wires) exiting from the EMI filters were switched, creating a situ... | Class II | Ortho-Clinical Diagnostics |
| Feb 12, 2016 | Helioseal Clear Refill 1 x 1.25 g, REF/Product Code/Art. No. 558521AN and He... | Complaints were received claiming the material failed to polymerize under the curing light. Afte... | Class II | Ivoclar Vivadent, Inc. |
| Jan 14, 2016 | BCS Automated Blood Coagulation Analyzer System, Multipurpose system for in v... | False short clotting times for PT on BCS and BCS XP with Dade Innovin can occur. This has also a... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jan 14, 2016 | BCS XP Automated Blood Coagulation Analyzer System, Multipurpose system for i... | False short clotting times for PT on BCS and BCS XP with Dade Innovin can occur. This has also a... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Dec 21, 2015 | Hip Preservation System Signature Series PreBent Burs under the following lab... | Metal shavings released from burs during use are due to contact between the bur and the hood of t... | Class II | ConMed Corporation |
| Dec 21, 2015 | VITROS 4600 Chemistry System, Catalog Number 6802445, Unique Device Identifie... | Increased U90-382 or 6LU condition codes generated by VITROS 250, 350, 5,1 FS, 4600 and 5600 Chem... | Class II | Ortho-Clinical Diagnostics |
| Dec 21, 2015 | VITROS 250 Chemistry Systems, Catalog 8132086, Unique Device Identifier No. 1... | Increased U90-382 or 6LU condition codes generated by VITROS 250, 350, 5,1 FS, 4600 and 5600 Chem... | Class II | Ortho-Clinical Diagnostics |
| Dec 21, 2015 | VITROS 350 Chemistry System, Catalog Number 6802153, Unique Device Identifier... | Increased U90-382 or 6LU condition codes generated by VITROS 250, 350, 5,1 FS, 4600 and 5600 Chem... | Class II | Ortho-Clinical Diagnostics |
| Dec 21, 2015 | VITROS 5,1 FS Chemistry System, Catalog Number 6801375, Unique Device Identif... | Increased U90-382 or 6LU condition codes generated by VITROS 250, 350, 5,1 FS, 4600 and 5600 Chem... | Class II | Ortho-Clinical Diagnostics |
| Dec 21, 2015 | VITROS 5600 Chemistry System, Catalog Number 6802413, Unique Device Identifie... | Increased U90-382 or 6LU condition codes generated by VITROS 250, 350, 5,1 FS, 4600 and 5600 Chem... | Class II | Ortho-Clinical Diagnostics |
| Nov 19, 2015 | Factor VIII Chromogenic Assay, REF/Catalog No. B4238-40, Siemens Material Num... | Factor VIII Chromogenic Assay Lot 44637 is showing an increased occurrence of irregular curves wh... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Nov 5, 2015 | Altrus Thermal Tissue Fusion Energy Sources, Catalog Numbers: 1) 60-9500-120 ... | Miscalibration of the Energy Source monitoring function, which may incorrectly sense the handpiec... | Class II | ConMed Corporation |
| Nov 3, 2015 | NAMIC CONVENIENCE KIT RENOWN REGIONAL MEDICAL CENTER, REF Catalog No. 6523002... | Procedure Products initiated the recall due to the inner lumen of the needles not meeting the int... | Class II | AngioDynamics Inc. |
| Nov 3, 2015 | VITROS 5600 Chemistry System, Catalog Number 6802413, Unique Device Identifie... | Software anomaly may allow VITROS Systems to sample and process assays while the fluids and reage... | Class II | Ortho-Clinical Diagnostics |
| Nov 3, 2015 | VITROS 3600 Chemistry System, Catalog Number 6802783, Unique Device Identifie... | Software anomaly may allow VITROS Systems to sample and process assays while the fluids and reage... | Class II | Ortho-Clinical Diagnostics |
| Nov 3, 2015 | VITROS 4600 Chemistry System, Catalog Number 6802445, Unique Device Identifie... | Software anomaly may allow VITROS Systems to sample and process assays while the fluids and reage... | Class II | Ortho-Clinical Diagnostics |
| Nov 3, 2015 | NAMIC CONVENIENCE KIT HOLYOKE HOSPITAL SPECIAL PROCEDURE KIT, REF Catalog No.... | Procedure Products initiated the recall due to the inner lumen of the needles not meeting the int... | Class II | AngioDynamics Inc. |
| Nov 3, 2015 | NAMIC CONVENIENCE KIT MERCY GENERAL HOSPITAL NEURO KIT, REF Catalog No. 601... | Procedure Products initiated the recall due to the inner lumen of the needles not meeting the int... | Class II | AngioDynamics Inc. |
| Nov 3, 2015 | NAMIC CONVENIENCE KIT SELF REGIONAL HEALTHCARE PV LEG PACK, REF Catalog No. 6... | Procedure Products initiated the recall due to the inner lumen of the needles not meeting the int... | Class II | AngioDynamics Inc. |
Frequently Asked Questions
When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.
All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.
Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.